FDA Keeps Limits on Other 'Plan B' Contraceptive

By

Jennifer Corbett Dooren

Updated Dec. 12, 2011 11:47 p.m. ET

The Food and Drug Administration denied a petition Monday by a reproductive rights advocacy group that sought to lift all prescription requirements for an older version of the Plan B emergency contraceptive pill on the eve of a federal court hearing on the issue.

The denial came a week after Department of Health and Human Services Secretary Kathleen Sebelius overruled the FDA and ordered it to reject an application from Teva Pharmaceutical Industries Ltd., for a different version of Plan B.

Teva was seeking agency approval to sell the newer version of the drug — a single tablet called Plan B One-Step—in store aisles to all women of child-bearing age.

While the decision means no immediate change for the prescription requirements on Plan B, it adds another twist to a contentious legal battle over whether young girls need a doctor's guidance to take the drug.

The older version of the drug requires women to take two pills 12 hours apart. In denying the petition, the FDA said it would need to see use- and label-comprehension studies for the two-step version of Plan B. The agency said studies of Teva's single-pill Plan B product "would not be transferable" to the drug's two-pill version.

Plan B One-Step and the older, generic versions of Plan B that require two pills are currently sold without a prescription to women age 17 and older. Women age 16 and younger require a prescription, so the products are kept behind pharmacy counters.

Both types of Plan B are designed to prevent pregnancy if taken within three days of unprotected intercourse. Teva no longer makes the two-pill version of Plan B though some generic makers still produce it.

In 2001 the Center for Reproductive Rights filed a petition with FDA seeking a ruling that would move Plan B— then sold by prescription to all age groups —out from behind the pharmacy counter. The same group also sued the agency in 2005 in federal court. In 2006, the FDA allowed Plan B to be sold without a prescription to women age 18 and older and also rejected the group's petition.

In 2009 the judge in the case ordered the FDA to reconsider its Plan B decision as well as the center's petition. Later the same year, the FDA approved Teva's single-pill Plan B formulation and allowed it to be sold without a prescription to women age 17 and older. At the time, FDA didn't act on the petition.

In 2010 the Center for Reproductive Rights asked the court to rule the FDA failed to fully act on the court's earlier order, and a hearing on the matter is scheduled for Tuesday.

"On the eve of a contempt hearing, the FDA has once again come up with an excuse to treat the approval of contraceptives differently from any other drug," said Nancy Northup, the group's chief executive.

Teva had submitted two studies to the FDA earlier this year seeking approval of its application to fully lift prescription requirements for Plan B One-Step. One study looked at whether adolescents could understand the drug's label. The second involved 345 girls ages 11 to 17 that was designed to simulate real-world use of the product. The company has said nearly 90% of the girls were able to properly use Plan B. The full study results haven't been made public.

In a letter to the Center for Reproductive Rights denying the petition, the FDA disclosed for the first time that Teva would have had three years of exclusivity for full non-prescription sales of Plan B One-Step if the application had been approved.

Last week, the FDA was prepared to lift the prescription requirement for Plan B One- Step. But Ms. Sebelius said the data submitted on the drug didn't prove it was appropriate for girls to take Plan B without a prescription, and she overruled the agency to block the decision. Ms. Sebelius, in a letter to the FDA, noted that 10% of females reach reproductive age by 11 years old.

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